Novavax awaits FDA decision on COVID-19 vaccine after positive committee vote

09-Jun-2022 - Last updated on 09-Jun-2022 at 14:08 GMT

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A meeting of the FDA’s vaccines and related biological products advisory committee (VRBPAC) voted Tuesday to recommend that the agency grant Emergency Use Authorization (EUA) for Novavax’ COVID-19 vaccine.

The committee voted 21 to 0 (with one abstention) to recommend authorization. The FDA will now make the final decision.

The COVID-19 vaccines currently available in the US are Pfizer/BioNTech’s mRNA Comirnaty; Moderna’s mRNA Spikevax; and J&J’s viral vector vaccine. If given the green light by the FDA, Novavax's vaccine (NVX-CoV2373) will become the first protein-based COVID-19 jab in the country.

The vaccine – created using the company’s recombinant nanoparticle tech and its saponin-based Matrix-M adjuvant – has received authorization for individuals aged 18+ in more than 40 countries, as well as an Emergency Use Listing from the WHO.

'An innovative approach to traditional technology'

Responding to Tuesday’s VRBPAC meeting, Stanley C. Erck, president and CEO of Novavax, said: "The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology. In the VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option.

“Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

The VRBPAC considered data from the Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the US and Mexico and was published in the New England Journal of Medicine.

The vaccine demonstrated 90.4% efficacy (95% confidence interval [CI], 82.9 to 94.6; P<0.001). Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.

The vaccine continues to be evaluated in the PREVENT-19 Phase 3 trial and a pediatric expansion of the trial.